Food allergy affects as many as 6% of young children and 3-4% of adults.(1,2) Peanut allergy is the leading cause of food-induced anaphylaxis treated in hospital emergency departments in the United States (3) and peanut and tree nut allergies account for approximately 80% of fatal and near-fatal anaphylactic reactions.(4-6) While the majority of children outgrow their allergy to milk, egg, wheat, and soy, allergies to peanut, tree nuts, fish and shellfish are often life-long. Currently, there are no treatments that can cure or provide long-term remission from food allergy. Traditional Chinese Medicine (TCM) has been used to treat various diseases for thousands of years. Chinese herbal medicine, particularly in the form of formulas that are composed of several herbs, is one of the major components in the practice of TCM. The Food Allergy Herbal Formula (FAHF-2) is a 9 herb formula (7-14) that has been demonstrated to be safe and effective in a murine model of peanut allergy.(15,16) Furthermore, FAHF-2 appears to be safe and well-tolerated in food-allergic patients. This protection from anaphylaxis in the murine model is associated with decreased IgE, increased lgG2a, decreased peripheral basophils, and decreased cell surface expression of FceRI on mast cells and basophils. Thus, we hypothesize that FAHF-2 is a safe and effective herbal therapy for food allergy and this protection is associated with suppression of food specific IgE while increasing food-specific IgG (and lgG4), decreased IgE epitope diversity, and suppression of basophil numbers and function. These aims will be investigated in a double-blind, randomized, placebo-controlled clinical trial, using standard protocols, including double-blind, placebo-controlled oral food challenges, to evaluate clinical outcomes including long-term efficacy. RELEVANCE: The goal of this study will be to validate the clinical efficacy of Chinese herbal medicine in food allergies and to elucidate the mechanisms of action of this herbal formula. This potential therapy has significant advantages over other treatments currently under investigation because it is administered orally, has a high safety profile, and may provide long-term protection from anaphylaxis.